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Boston Scientific and Cook Medical questioned parts of the FDA’s guidance on premarket notifications for metal expandable biliary stents and their delivery systems — including limits on eligibility for the Special 510(k) program and some recommended test methods in the agency’s draft released in July. Read More
The FDA needs to do more to ensure the cybersecurity of networked medical devices, according to a new report from the HHS Office of Inspector General. Read More
The agency still has concerns about use of the stents for cardiovascular indications unless they have been cleared for CV indications through a PMA. Read More
AdvaMed asked the FDA for more examples of combination product types and manufacturing processes for which good manufacturing practices diverge from standard combination product CGMPs. Read More
Manufacturers receiving a heparin sodium drug substance or API represented as “USP” for use in a combination product should document that the substance has been tested according to the current USP drug substance monograph, the agency said. Read More